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By David Schultz

Jan. 2 — A lawsuit filed against the Environmental Protection Agency over its regulation of antimicrobial products containing nanosilver could, if successful, force companies to take hundreds of products off the shelves.

The lawsuit, filed by a coalition of environmental groups in federal court in Washington, D.C., seeks to force the EPA to regulate nanosilver as a new antimicrobial pesticide, which would require anyone seeking to manufacture it to first apply for a formal pesticide registration. However, there are currently several hundred products already on the market that contain the nanoscale substance.

“These products should be recalled if they’re already on the market,” George Kimbrell, a senior attorney with the Center for Food Safety, the lead plaintiff in the case, told Bloomberg BNA. “Before commercialization happens, the agency needs to review it.”

Lawrence Culleen, a partner in the environmental practice group at the law firm of Arnold and Porter LLP, said this could create a fair amount of chaos for many companies. “It would be difficult to deal commercially with that position if the EPA were to do that,” he told Bloomberg BNA.

Lack of Response

At the heart of the environmental groups' lawsuit is a legal petition they filed with the EPA in 2008 asking it to treat nanosilver as a pesticide and to regulate it under the Federal Insecticide, Fungicide, and Rodenticide Act.

At the time, the petitioners said they had identified at least 260 products that contained the nanoscale substance—everything from sanitizing sprays and water purifiers to cutlery, washing machines and baby bottles. Kimbrell said silver behaves very differently when broken down to the nanoscale and that it poses unknown toxicity risks.

Since then, the EPA has begun to develop a framework for how it will handle this burgeoning technology. It has issued conditional registrations to some products containing nanosilver while also conducting enforcement actions against other unregistered products that were marketed as having antimicrobial properties.

However, Kimbrell said the EPA never responded to the coalition's 2008 petition. As a result, the coalition is taking the EPA to court in an attempt to force it to do so.

“They need to issue regulatory guidance to industry,” Kimbrell said.

An EPA spokeswoman declined to comment, citing the ongoing litigation.

Broad Impact

Beyond the environmental groups filing the lawsuit and the companies it could affect, wastewater treatment facilities also have a stake in the outcome. Runoff of nanosilver into the water system could potentially inhibit the beneficial bacteria many facilities use to treat sewage or could also go through a facility untreated and collect in bodies of water.

“At this point we don’t really know enough about it to say if it’s a risk,” Cynthia Finley, regulatory affairs director of the National Association of Clean Water Agencies, told Bloomberg BNA. “We’d like to see EPA do more work on this."

But Culleen of Arnold and Porter said this case could have an even broader impact if it sets a precedent for how the EPA must handle citizen-filed petitions. “The court will have to ask whether it’s in the EPA's discretion or not to respond,” he said.

Culleen said this case and another recently decided case over the regulation of lead content in firearm ammunition could determine how much power the petition process has.

In the ammunition case, a federal appeals court panel ruled Dec. 23 that the EPA can't refuse to respond to a petition on the grounds that the petition is similar or redundant to an earlier one.

To contact the reporter on this story: David Schultz in Washington at dschultz@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com

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